MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; BACK TABLE COVER IN CATARACT PACK

Catalog Number LYN051BSOGA

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/14/2016

Event Type  Injury  

Manufacturer Narrative

Blue fibers thought to be from back table cover in cataract pack found in surgical site.Fibers flushed out of site, incision did not have to be enlarged to remove the fibers.No injury or need for further intervention.Sample has not been returned, have not confirmed the issue or identified a root cause.Due to the need for intervention to remove the blue fibers this medwatch is being filed.Device not returned.

Event Description

Blue fibers thought to be from the back table cover were seen in the surgical site.

• Type of Device: BACK TABLE COVER IN CATARACT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline place; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 6026500
• MDR Text Key: 57318563
• Report Number: 1423395-2016-00047
• Device Sequence Number: 1
• Product Code: OJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LYN051BSOGA
• Device Lot Number: 16DB2569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention